Container Closure Integrity (CCI) Testing Scientist in Eden Prairie, Minnesota at TCP Reliable Manufacturing Inc

We are looking for a Container Closure Integrity (CCI) Testing Scientist to help grow our CCI testing capabilities and serve as a key technical resource within the laboratory. This role requires hands-on experience performing container closure or package integrity testing using USP <1207> technologies, along with 2–3 years of laboratory experience in a pharmaceutical, biotechnology, contract testing, medical device, or combination product environment operating under cGMP or comparable quality standards. You will take an active role in executing testing, analyzing results, troubleshooting instrumentation, and supporting method development and validation. If you’re excited to apply your CCI experience in a hands-on laboratory environment while continuing to grow your technical expertise, we want to hear from you!

WHO WE ARE:

DDL, Inc. is a third-party testing facility dedicated to helping medical device and pharmaceutical companies across the globe bring products to market. For over 30 years, DDL has provided extraordinary customer service and specialized testing expertise to the medical device, pharmaceutical, and consumer goods industries for our clients’ safety and efficacy testing. We help save lives by providing the highest standards for package, product and material, and Container Closure Integrity testing.

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities):

The Container Closure Integrity (CCI) Testing Scientist is responsible for performing, developing, and validating container closure integrity and package integrity test methods in support of contract testing for pharmaceutical, biotechnology, medical device, and combination product clients in DDL’s FDA-registered cGMP laboratory. This role applies the principles of USP <1207> Package Integrity Evaluation—Sterile Products and its subchapters <1207.1>, <1207.2>, and <1207.3> to demonstrate that sterile product packages prevent microbial ingress and the loss or gain of product, gases, and moisture throughout the product life cycle.

This position executes deterministic and probabilistic leak test methods, supports method selection and justification and ensures all testing is performed in accordance with current Good Manufacturing Practice, data integrity principles, approved protocols, and client requirements. The Scientist works closely with the Laboratory Director, CCI Technology Lead, Project Management, Quality Assurance, and clients to deliver accurate, defensible, and timely CCI results supporting product release, stability programs, packaging qualification, and regulatory submissions.

Key Responsibilities:

• Perform container closure integrity testing of sterile product packages, including vials, prefilled syringes, cartridges, flexible bags, autoinjectors, and other combination product and medical device packaging, in accordance with USP <1207>, approved SOPs, protocols, and client specifications.
• Execute deterministic leak test methods described in USP <1207.2>, such as vacuum decay, pressure decay, high voltage leak detection (HVLD), laser-based headspace gas analysis (oxygen, carbon dioxide, moisture, and pressure), helium tracer gas mass spectrometry, and mass extraction.
• Execute probabilistic leak test methods, such as dye ingress (including UV/Vis spectrophotometric quantitation of dye), microbial challenge by immersion, and bubble emission, using appropriate sample sizes, controls, and acceptance criteria.
• Perform package seal quality testing described in USP <1207.3>, such as residual seal force, seal strength, and burst testing, and related package integrity testing to applicable ASTM and ISO 11607 standards.
• Prepare, characterize, and use positive and negative control samples, including laser-drilled micro-holes, micropipettes, capillaries, and other artificial leak defects, and verify defect size using microscopy, gas flow measurement, or other appropriate techniques.
• Perform CCI testing at stability time points, after transportation or stress conditioning, and for products stored at challenging conditions such as frozen, ultra-low temperature (e.g., –80 °C), and dry ice storage.
• Support CCI method selection and justification based on product and package characteristics, headspace content, maximum allowable leakage limit (MALL), and the leak sizes each technology can reliably detect.
• Develop, optimize, and transfer CCI test methods; author and execute method validation protocols and reports demonstrating limit of detection, accuracy, precision, specificity, and robustness consistent with USP <1207.1>.
• Establish instrument test parameters, pass/fail limits, and system suitability criteria using positive controls and statistically appropriate sample sets.
• Prepare technical summaries and reports that clearly communicate CCI results, method capability, and conclusions to clients and internal stakeholders.
• Perform all laboratory activities in compliance with cGMP, applicable portions of 21 CFR Parts 210, 211, and 820, ISO/IEC 17025, data integrity (ALCOA+) principles, and approved procedures.
• Accurately record, review, and document test results, raw data, and instrument printouts in laboratory notebooks, worksheets, and LIMS in a contemporaneous and attributable manner.
• Review laboratory data for completeness, accuracy, and compliance with approved methods before submission for secondary review or reporting.
• Support internal audits, client audits, and regulatory inspections by providing documentation and technical explanations of CCI methods and results.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results, atypical events, and deviations; perform root cause analysis and support CAPA implementation.
• Author, revise, and periodically review SOPs, test methods, worksheets, and forms supporting CCI and package integrity testing.
• Participate in client technical discussions on study design, method selection, sample quantity requirements, and interpretation of results as directed by the Laboratory Manager and Project Management.
• Operate, maintain, calibrate, and troubleshoot CCI instrumentation; coordinate preventive maintenance, calibration, and instrument qualification (IQ/OQ/PQ) activities with metrology and equipment vendors.
• Prepare and standardize reagents, dye solutions, microbial challenge media, and reference standards used in testing.
• Follow approved safety requirements for handling drug products, biological materials, compressed gases, cryogenic materials, high voltage equipment, and chemical waste, and use required personal protective equipment.
• Maintain a clean, organized, and safe laboratory workspace and report unsafe conditions or safety risks to the Laboratory Manager and Environmental Health and Safety.
• Complete required training on time and maintain competency in CCI test methods, GMP documentation, and safety practices.
• Maintain current knowledge of USP <1207> and related compendial chapters (e.g., USP <381> and <382>), EU GMP Annex 1, applicable FDA guidance, and relevant ASTM and ISO 11607 standards.
• Support cross-training, workload balancing, and team coverage needs as assigned.
• Other duties as assigned

WHAT YOU NEED TO SUCCEED (Minimum Qualifications):

• Bachelor’s degree in chemistry, biology, microbiology, pharmaceutical sciences, materials science, engineering, or a related scientific discipline; equivalent combination of education and relevant regulated industry experience may be considered.
• Minimum of 2–3 years of laboratory experience in a cGMP-regulated pharmaceutical, biotechnology, contract testing, medical device, or combination product environment.
• Hands-on experience performing container closure or package integrity testing using one or more USP <1207> technologies (e.g., vacuum decay, HVLD, headspace gas analysis, helium leak detection, dye ingress).
• Experience preparing or using positive controls and supporting CCI method development, validation, or transfer.
• Experience with UV/Vis spectroscopy, light microscopy, or other analytical techniques that support CCI test methods.
• Experience supporting OOS and deviation investigations, internal and client audits, or FDA inspections.
• Microsoft Office
• LIMS / Electronic Laboratory Notebook (ELN)
• QMS System
• CCI instrument software (e.g., vacuum decay, HVLD, headspace analyzer)

WHAT WILL SET YOU APART (Competencies Required):

• Working knowledge of USP <1207> principles, including deterministic versus probabilistic methods, leak size and MALL concepts, positive control use, and method validation expectations.
• Strong understanding of cGMP requirements, Good Documentation Practices, and data integrity principles.
• Ability to troubleshoot instrumentation and evaluate atypical results using sound scientific judgment.
• Strong written and verbal communication skills, including the ability to write clear protocols, reports, and investigations.
• Excellent attention to detail, organizational skills, and ability to manage multiple client projects and priorities in a fast-paced laboratory.

It is DDL’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.